Kornimate/medical-research-clean huggingface dataset:
a study of lanadelumab in persons with hereditary angioedema (hae) type i or ii in north america

Conditions: Hereditary Angioedema (HAE)

Summary: the main aim of this study is to compare the hae attack rate before and after lanadelumab treatment was started in persons with hereditary angioedeme type i or ii. data from participants will be collected for at least 24 months. participants will report information in a smartphone application at study start and then every 3 months until the study ends; data will also be collected by the study doctor during routine clinic visits.


Eligibility criteria:
inclusion criteria: * voluntarily provide written, signed, and dated (personally or via a legally-authorized representative) informed consent/and assent as applicable to participate in the study. expression of understanding and agreement by fully informed parent(s) or legal guardian is required to permit the investigator to enroll a child in this study. the choice of the terms parental consent or parental permission in different regions may reflect local legal/regulatory and ethical considerations. * diagnosis of hae type i or type ii. * ability to use a mobile device for data collection in the study. exclusion criteria: * participation in any interventional clinical trial at the time of enrollment. * unable to provide written, signed, and dated informed consent/assent. * investigator believes that the participant is not a suitable candidate for the study.
reletex for nausea in gerd patients

Conditions: Nausea

Summary: gastroesophageal reflux disease (gerd) is a highly prevalent condition that is frequently encountered in the health care setting. it affects roughly 40% of americans monthly and 10% weekly. of those with gerd, there exists a cohort that experience nausea with or without vomiting that is unresponsive to ppi's and anti-emetics. for these patients, treatment options are limited and these symptoms may substantially alter their quality of life. new and novel therapies emerging include neuromodulation devices that may affect the central pathways leading to these symptoms. of these, the reletex band has been tested and proven efficacious in the treatment of nausea and vomiting associated with pregnancy, chemotherapy, and surgery, in addition to standard anti-nausea medications. the investigators propose that through a similar mechanism, this device as an adjunct to ppi's and anti-emetics will reduce gerd-associated the nausea with or without vomiting, and by so doing, improve the quality of lives in this patient population.


Eligibility criteria:
inclusion criteria: * any patient over the age of 18 with clinically diagnosed gerd as evidenced by the gerdq assessment tool and/or ambulatory ph/ ph- impedance monitoring with a component of nausea with or without vomiting. * continued symptoms despite a stable dose of fda approved daily ppi therapy in addition to or without supportive anti-emetics. we will include patients with twice a day ppi dosing, as this is a standard treatment for ppi non-responders. * previous gastric emptying study performed as part of the standard care work-up of nausea and vomiting. patients will be recruited regardless of the results and this information will only be used as a potential predictor for symptom response. exclusion criteria: * currently participating in a concurrent clinical trial or completed another trial within past 8 weeks. * prior gastrointestinal surgery of the esophagus and stomach. * severe esophagitis (los angeles esophagitis grade c and above), barrett's metaplasia or eosinophilic esophagitis, achalasia or spastic motor disorder * unstable medical illness with ongoing diagnostic work-up and treatment. patients with well-controlled hypertension, diabetes and a remote history of ischemic heart disease that is deemed stable, as judged by the physician-investigator can be included. current drug or alcohol abuse or dependency. * current neurologic or cognitive illness or impairment which would make the patient an unsuitable candidate for hypnosis. this will be determined by the investigators before randomization using the mini mental status exam in patients with suspected impairment. * severe mental illness, e.g., uncontrolled major depression with suicidal ideation, active psychosis, diagnosis of schizophrenia-spectrum disorder. * those with nickel, gold, or other metal allergies. * those with other neuromodulators or implanted electrical devices such as cardiac pacemakers, aicd's, neurostimulators or transcutaneous electrical nerve stimulation devices (tens units). * females who are or might become pregnant during the study.
disposition of intravenous paracetamol in young women

Conditions: Pain

Summary: compared to early postpartum (10-15 weeks) observations, paracetamol clearance was significantly higher (21.1 vs 11.7 l.h-1, + 80 %) at delivery. this higher clearance was due to a disproportional increase in glucuronidation (11.6 vs 4.76 l.h-1, + 144 %), a proportional increase in oxidation clearance (4.95 vs 2.77 l.h-1, 78 %) and primary renal clearance (1.15 vs 0.75 l.h-1, 53 %) \[kulo et al, int j obstet anesth\]. this increase in glucuronidation clearance may in part be driven by oestradiol, and may explain within and between individual differences in paracetamol metabolism (e.g. oral contraceptives, follicular vs luteal phase, postpartum, pregnancy, or duration of pregnancy) in young women. based on a pooled analysis, investigators aimed to further explore the impact of these covariates on paracetamol metabolism based on plasma and urine collections in women at delivery, in postpartum (early, or late) and healthy volunteers, either or not on oral contraceptives (oc) following intravenous (iv) paracetamol administration.

this study aims to perform a pooled analysis of: 1. paracetamol pk data recently published in 47 pregnant women. in these cases, iv paracetamol was administered q6h after delivery (caesarean) for 24 h. 8 were recruited a second time for an additional single dose pk study in postpartum (kulo et al, br j clin pharmacol 2013). 2. the pk data as initially published by gregoire et al, but limited to female volunteers, all on oral contraceptives (n=14) (gregoire et al, clin pharm ther 2007) 3. a dataset in 8 young women not on oral contraceptives, iv paracetamol, single dose.

Eligibility criteria:
inclusion criteria: 1. informed consent 2. for patients (pregnant women at delivery), there has to be a clinical indication (post caesarean analgesia, npo) to administer iv paracetamol. exclusion criteria: 1. intolerance to paracetamol 2. withdrawal of informed consent.

Keywords: pharmacokinetics pregnancy oral contraceptives oestradiol
minoxidil 1% for eyebrow enhancement

Conditions: Eyebrow Hypotrichosis; Thin Eyebrow

Summary: the purpose of the study is to compare efficacy and safety of minoxidil 1% versus placebo in enhancement of eyebrows.


Eligibility criteria:
inclusion criteria: * male or female aged 18-60 years * hypotrichosis of eyebrows * healthy * informed consent obtained exclusion criteria: * underlying diseases * alopecia areata or trichotillomania * thyroid diseases * pregnancy or breast feeding * previous eyebrow tattoo, trauma or accident. * history of eyebrow or hair medications in 6 months * history of minoxidil or its ingredient allergy * history of eyebrow surgery.
apple heart study: assessment of wristwatch-based photoplethysmography to identify cardiac arrhythmias

Conditions: Atrial Fibrillation; Arrhythmias, Cardiac; Atrial Flutter

Summary: the apple heart study (ahs) is a research study conducted to evaluate whether the apple heart study app can use data collected on the apple watch to identify irregular heart rhythms, including those from potentially serious heart conditions such as atrial fibrillation. up to 500,000 can participate in the study.


Eligibility criteria:
inclusion criteria: possession of the following at time of eligibility screening, ascertained from automatic hardware/software/device pairing check: * iphone (5s or later) with ios version 11.0 or later defined as iphone model/ios version used to complete screening eligibility. * apple watch (series 1 or later) with watchos version 4.0 or later defined as apple watch model/watchos paired with iphone used to complete screening eligibility. * current resident of the united states at time of eligibility screening, defined by self-reported state of residence within the 50 states of the united states or district of columbia. * proficient in written and spoken english, defined by self-report of comfort reading, writing, and speaking english on iphone. * valid phone number associated with iphone, ascertained from self-report. * valid email address, ascertained from self-report. exclusion criteria: * self-reported diagnosis of atrial fibrillation. * self-reported diagnosis of atrial flutter. * currently on anti-coagulation therapy.
cutivate lotion hpa axis pediatric study

Conditions: Atopic Dermatitis

Summary: a multi-center, open-label, phase iv, unblinded study using cutivate (fluticasone propionate, 0.05%)lotion and it's possible effects on the hpa axis of infants diagnosed with atopic dermatitis.


Eligibility criteria:
inclusion criteria: * subjects are 3-12 months of age * subjects diagnosed with atopic dermatitis (ad) and have ≥35% of body surface area * subjects meet protocol specific ad signs and symptom severity score exclusion criteria: * subjects with conditions effecting the hpa axis * subjects with clinically significant systemic disease * subjects who require treatment with systemic or topical retinoids during the study * subjects who have been treated with various chronic therapies identified in the protocol * subjects who have received other investigational drug treatment within 30 days prior to study entry
effects of a female hormone balance supplement on symptoms of polycystic ovary syndrome and severe premenstrual syndrome

Conditions: Polycystic Ovary Syndrome; Premenstrual Syndrome

Summary: this is a virtual single group study that will last 12 weeks. participants will take 1 scoop of the female hormone balance supplement, and mix it with their drink of choice every morning. questionnaires will be completed at baseline, 1 week, 2 weeks, 4 weeks, and 12 weeks


Eligibility criteria:
inclusion criteria: * women aged between 18 - 55 * bmi less than 35 * self-reported concerns around irregular menstrual cycles and ovulation, mood swings, stress, irritability, and low energy * generally healthy - don't live with any uncontrolled chronic disease * self-reported symptoms of pcos - irregular periods * self-reported concerns with hormonal skin issues exclusion criteria: * anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders * anyone with known severe allergic reactions * anyone who is pregnant, breastfeeding, or attempting to become pregnant * unwilling to follow the study protocol
monocentric pilot study, for a randomized, crossover, blinded trial: comparison of the therapeutic efficacy of low frequency repeated transcranial magnetic stimulation on cortical area 9 compared to brodmann area 46 in the treatment of depressive disorders.

Conditions: Patients With Resistant Depressive Disorders

Summary: repetitive transcranial magnetic stimulation (rtms) is a new therapeutic tool used in psychiatry. non-invasive, well tolerated and requiring no premedication, it is performed on an outpatient basis. the principle of this technique is to stimulate the cerebral cortex from an electromagnetic coil placed on the scalp. unlike electroconvulsive therapy, rtms induces an electrical current on a well-defined region of the cerebral cortex. in psychiatry, this technique is mainly considered in the treatment of depressive disorders resistant to antidepressant medication. the brain target, obtained from brain imaging data in depressed patients, is the dorsolateral prefrontal cortex (dlpfc). the food and drug administration (fda) has recognized the interest of rtms for treating depressive disorders (october 7, 2008). however, some stimulation parameters still need to be optimized before rtms can be considered a therapeutic method in its own right and used routinely. indeed, its effectiveness over time has not yet been evaluated, and rtms has shown a lack of reproducibility between subjects \[foucher, 2007\]. finally, the therapeutic results of rtms are very modest whatever the study \[daskalakis, 2008\]. additional studies are therefore needed to optimize stimulation parameters.


Eligibility criteria:
inclusion criteria: patients with resistant depressive disorders (hamilton-17-item scale \> 22, failure ≥ 2 antidepressants) with at least one of the following criteria : * venlafaxine treatment failure (unlike the national phrc, patients who receive/have received venlafaxine treatment for the current depressive episode are included), * therapeutic failure in phrc national rtms 2007, * refusal to participate in the phrc national rtms 2007. exclusion criteria: * bipolar disorders: type i or ii, * depression with psychotic characteristics, * schizophrenia, * risky or harmful use of alcohol and/or an illicit psychoactive substance, * dependence on alcohol and/or an illicit psychoactive substance, * sick and hospitalized under duress or under legal protection (guardianship, curatorship), * contraindication to the practice of rtms; personal history of seizures, history of neurological or neurosurgical pathologies, metallic prosthetic materials or foreign bodies (pacemaker, etc...), * contraindication to brain mri, * pregnancy or breastfeeding in progress * resistance to escitalopram
is it possible to treat cyanide poisoning with hbo?

Conditions: Carbon Monoxide Poisoning From Fire Accidents

Summary: people who has been in a fire accident have been shown often to be cyanide poisoned as well as poisoned with carbon monoxide(co). according to recommendations from the danish health agency people who are co poisoned must be treated with hyperbaric oxygen (hbo). we want to see if hbo treatment can also treat cyanide poisoning. the hypothesis is that as cyanide binds the same place in the mitochondria as co cyanide will be detached from the mitochondria like co and diffuse back to the blood.this way it will be easier to treat with hydroxycobalamin.


Eligibility criteria:
inclusion criteria: * going to receive hbo treatment for carbon monoxide poisoning from fire accidents exclusion criteria: * under 18 years
role of some biochemical indices for prediction of acute kidney injury in intensive care unit patients in upper egypt

Conditions: Acute Kidney Injury

Summary: 1. we will investigate the relation between the triglyceride-glucose index and the development of aki in icu. 2. to detect whether the tgi is a predictor of poor outcome (requirement of renal replacement therapy, or 14-day in-hospital mortality, and length of hospital stay) in icu. 3. compare tgl, neutrophil-to-lymphocyte ratio, and clinical score (sequential organ failure assessment sofa score) as predictors of poor outcome in icu.

acute kidney injury (aki) is a common clinical syndrome with a broad aetiological profile. it complicates about 5% of hospital admissions and 30% of admissions to intensive care units (icu). during last 20 years has been a significant change in the spectrum of severe aki such that it is no longer mostly a single organ phenomenon but rather a complex multisystem clinical problem. mortality from aki, when part of mof, remains over 50%. in the past few decades, the understanding of aki has greatly improved, but early diagnosis remains a great challenge. the performance of traditional kidney function index and serum creatinine is very limited for the early diagnosis of acute kidney injury the triglyceride glucose index (tgi) has been suggested as a useful marker of insulin resistance. previous studies have shown that tgi is associated with many diseases, but no study has examined the relationship between tgi and aki . the primary objective of the present study was to investigate the relationship between tgi and aki.

Eligibility criteria:
inclusion criteria: * the selected patients will be with the following inclusion criteria: patients admitted to icu within 24 hours exclusion criteria: * we will exclude those with any of the following: 1. patients diagnosed more than 24 hours. 2. patients with missing data of triglyceride or glucose. 3. patients \&amp;lt;18years old. 4. patient with advanced liver disease and chronic kidney disease with or without dialysis
safety of autologous cord blood cells for preterm infants.

Conditions: Safety Issues; Effect of Drugs; Neonatal Death

Summary: to assess the safety of autologous volume- and red blood cell (rbc)-reduced non-cryopreserved umbilical cord blood (ucb) cell infusion to preterm infants.

preterm birth complications are one of the leading causes of death among children under 5 years of age. despite advances in medical care, many survivors face a lifetime of disability, including mental and physical retardation, and chronic lung disease. more recently, both allogenic and autogenic cord blood cells have been applied in the treatment of neonatal conditions such as hypoxic-ischemic encephalopathy (hie) and bronchopulmonary dysplasia (bpd). objective-to assess the safety of autologous volume- and red blood cell (rbc)-reduced non-cryopreserved umbilical cord blood (ucb) cell infusion to preterm infants. method- this study was a phase i, open-label, single-arm, single center trial to evaluate the safety of autologous, volume- and rbc-reduced non-cyropreserved ucb cell (5×107cells/kg) infusion for preterm infants \<37 weeks gestational age. ucb cell characteristics, pre- and post- infusion vital signs, laboratory investigations were recorded. clinical data including mortality rates and preterm complications were recorded. results-after processing, (22.67±4.05) ml ucb cells in volume, (2.67±2.00)×108 cells in number, with (22.67±4.05)×106 cd34+, and (3.72±3.25)×105colony forming cells (cfu-gm), (99.7±0.17%) vitality were infused to 15 preterm infants within 8 hours after birth. no adverse effects were noticed during treatment. all fifteen patients who received ucb infusion survived. the duration of hospitalization ranged from 4 to 65 (30±23.6) days. regarding preterm complications, no bpd, necrotizing enterocolitis (nec), retinopathy of prematurity (rop) were observed. there were 1/15 (7%) infant with intraventricular hemorrhage (ivh), and 5/15 (33.3%) infants with ventilation-associated pneumonia, 10/15(66.67%) with anemia respectively. conclusions-collection, preparation and infusion of fresh autologous ucb cells to preterm infants is feasible and safe. adequately powered randomized controlled studies are needed.

Eligibility criteria:
inborn infants admitted to the neonatal intensive care unit (nicu) of guang dong women and children's hospital were eligible if they were: 1. preterm: \<37 weeks gestation 2. without congenital abnormalities; 3. without maternal chorioamnionitis 4. had available ucb. 5.the mother was negative for hepatitis b (hbsag and/or hbeag) and c virus (anti-hcv), syphilis, hiv (anti-hiv-1 and -2) and igm against cytomegalovirus, rubella, toxoplasma and herpes simplex virus.

Keywords: autologous umbilical cord blood stem cells safety effect neonates mechanism
phase 4 study to evaluate treatment optimization with once-daily insulin glargine 300 u/ml

Conditions: Type I Diabetes Mellitus

Summary: primary objective: to evaluate the efficacy of switching treatment from twice-daily basal insulin to once-daily insulin glargine (u300) as part of basal bolus regime in terms of glycated hemoglobin improvement (reduction by at least 0.3%), in uncontrolled type 1 diabetes mellitus patients. secondary objectives: * to evaluate other efficacy parameters in terms of glycemic control as well as safety including hypoglycemia events, weight changes, and adverse events. * to evaluate the effect of insulin glargine (u300) on diabetes treatment satisfaction and fear of hypoglycemia as well as patient's satisfaction regarding the number of daily injections.

the estimated average study duration is 29 weeks, including run-in period of 4 weeks; treatment period of 24 weeks, and follow-up period of 1 week.

Eligibility criteria:
inclusion criteria : * male or female. * age ≥ 18 years. * with type 1 diabetes mellitus. * being treated twice-daily with any basal insulin in combination with prandial rapid-acting insulin analogue for at least one year. * have an glycated hemoglobin (hba1c) measurement of 7.5% - 10.0% at study entry. * patients who have signed an informed consent form. exclusion criteria: * type 2 diabetes mellitus. * known hypoglycemia unawareness * repeated episodes of severe hypoglycemia or diabetes ketoacidosis within the last 12 months. * end-stage renal failure or being on hemodialysis. * any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening or baseline, or any major systemic disease resulting in short life expectancy that in the opinion of the investigator would restrict or limit the patient's successful participation for the duration of the study. * known hypersensitivity / intolerance to insulin glargine or any of its excipients. * patients treated with glucagon like peptide agonists. * use of systemic glucocorticoids (excluding topical application or inhaled forms) for one week or more within 90 days prior to the time of screening. * pregnant or lactating women. * women of childbearing potential with no effective contraceptive method. * participation in another clinical trial. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.